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FDA 510(k)

ENT PACKINGS, WICKS, WIPES, AND SPONGES

K-Number: K954449 · 1995-11-14

ApplicantOasis
Decision Date1995-11-14
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENT PACKINGS, WICKS, WIPES, AND SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Oasis. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K954449. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENT PACKINGS, WICKS, WIPES, AND SPONGES?

ENT PACKINGS, WICKS, WIPES, AND SPONGES is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Oasis. The 510(k) number is K954449.

When did ENT PACKINGS, WICKS, WIPES, AND SPONGES receive FDA 510(k) clearance?

ENT PACKINGS, WICKS, WIPES, AND SPONGES received FDA 510(k) clearance on 1995-11-14, under 510(k) number K954449.

Who is the listed applicant for ENT PACKINGS, WICKS, WIPES, AND SPONGES?

The FDA 510(k) record lists Oasis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENT PACKINGS, WICKS, WIPES, AND SPONGES?

The FDA product code for ENT PACKINGS, WICKS, WIPES, AND SPONGES is LYA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oasis as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001464DISPOSABLE H-PE MICROKERATOME BLADES

Related Devices (Code: LYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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